WHO has directed all the governments’ worldwide, to make sure that the drugs and devices made should meet acceptable standards of quality, safety and efficacy. The basic goal of quality control is to ensure that the products, services, or processes provided meet specific requirements and are dependable, satisfactory, and fiscally sound. The quality has to be incepted and maintained into the product from the start to the end. Thus quality control involves the examination of a product, service and process followed by the biotechnology, medical device, pharmaceutical and food companies according to the international environmental, safety and regulatory standards.
Quality assurance is a part of the overall management of any project, while quality control is the technical activity and documentation to pursue quality objectives. Quality is an integral and vital component of any sampling and analysis effort. Both Quality Assurance (QA) and Quality Control (QC) are intended to ensure that the data collected are adequate to fulfill project objectives. These concepts are of vital importance in highly demanding and quality conscious industry like Pharmaceutical industry. The Pharmaceutical Quality Assurance & Quality Control program is an innovative and unique program where basic concepts as well as advance topics are covered. The industry program aims to prepare aspirants for career in quality assurance department of biotechnology, medical device, and pharmaceutical food companies or as an independent consultant.
The course has been framed with the following objectives:
- This course helps participants to understand and implement quality assurance and quality control measures effectively for the particular operation during drug development in the Pharma Industry.
- The course imparts students with the knowledge of quality assurance guidance GMP, GLP and ICH in all areas that impact drug quality.
- Students will get knowledge about quality system and Good Documentation Practices (GDPs), SOPs and principles of product complaints, product recall, returned goods, change control and CAPA.
- The course equips students to manage GMP and quality related issues as well as various regulatory requirements.
- The course describes the essential knowledge of regulatory process across a broad range of healthcare products including medical devices, pharmaceutical, biologics and combination products to the students in great detail.
The Pharma Quality Assurance and Control Course is easy to learn and comprehensive. It teaches not only the basic concept related to the subject, but also covers advanced topics as well. This course will help participants to understand and implement quality assurance and quality control for the particular operation during drug development. The course helps in better understanding of drug development process and its importance in the Pharma Industry and appraise them for following careers.
- Quality Assurance Technicians or Analysts
- Quality Assurance or Control Managers
- Quality Researcher
- Quality Assurance Engineer
- Quality Assistant
- Module 1– Pharma Regulation Practices and Procedure
- Module 2– Pharma Patents, IPR and Regulation
- Module 3– Pharma Regulatory Regime in USA, EU and India
- Module 4– Clinical Trials & Regulation
- Module 5– Good Manufacturing Practices, Quality Assurance and Regulation
- Module 6– Regulatory Compliance for Pharma and Biotech Products
Any Science Graduate